HEAL Study
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (CHOICES)
Short Description
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.
Release Date
Mar 07, 2024
This is an open-label, randomized, pilot trial of XR-NTX vs. treatment as usual (TAU) for treatment of opioid and alcohol use disorders in HIV-infected patients, whose goal is to determine the acceptability and feasibility of XR-NTX in HIV practice and inform development of a multi-site comparative effectiveness trial of XR-NTX vs. TAU in HIV clinics. During the study start-up period, we will conduct a survey of HIV provider attitudes toward opioid antagonist therapy at 15 high-volume HIV clinics to assess willingness to prescribe antagonist therapy and inform the site selection process (Aim 1). During pilot study implementation, we will survey HIV-infected patients regarding attitudes toward opioid antagonist therapy (Aim 2), track rate of participant recruitment (Aim 3), and randomize those who have untreated opioid and/or alcohol use disorders to receive XR-NTX vs. TAU (Aim 4). Participants will attend study visits every 4 weeks for 16 weeks. Treatment initiation will be assessed at 4 weeks and retention at 16 weeks (4 XR-NTX injections). Randomization will continue until a maximum of 50 participants or 12 months are reached. Pilot study duration will be a maximum of 17 months (maximum 12 months recruitment + 5 months study participation for those enrolled at the end of the recruitment period). We will assess feasibility of a multi-site trial of XR-NTX vs. TAU by addressing four pilot study specific aims.
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